Department of the Navy Human Research Protection Program
Research Protocol Documentation for
Investigators, IRBs, and Headquarters-Level Administrative Review
Background: Department of the Navy commands, through their investigators and Institutional
Review Boards (IRB), must maintain adequate documentation of human subject research
protocols and IRB records. [32 CFR 219 and SECNAVINST 3900 series]
Directions: Use the following chart to determine the documentation investigators and IRBs must
retain and copies of documents commands must provide to DON HRPP for headquarters-level
administrative review. Not all the items apply to every research protocol. N/A = Not Applicable
Document Item
Initial Review of New Protocol
1. Document granting approval to start
research (including granting exemption)
2. Education and training documentation
3. Scientific review and approval Document
4. Approved research protocol – with
version # and date
5. Instruments (e.g., psychological tests)
6. Questionnaires (e.g., diaries,
demographics)
7. Data collection forms, CRFs
8. Recruiting, advertising materials, or
letters of introduction
9. Subject information sheets
10. IRB-approved consent documents with
expiration date/IRB stamp (all finals)
11. Parental Permission (same as above)
12. Child Assent (same as above)
13. Foreign Language Translations of
Consent / Assent / Parental Permission
14. Other reviews (RAD Safety, RDRC, etc.)
15. Survey Approval (OPNAV) *
16.
17.
18.
19.
Verification Worksheet (CIP only)
Standards of Conduct/Attestations
Resource Requirements (CIP only)
Departmental Impact Statement (CIP
only)
Investigator
File
IRB
File
Send to
DON
HRPP
X
X
X
X
X
N/A
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
DON HRPP Document List - PI-IRB-HQR FINAL (Mod) 7 Nov 2006.doc
Comments
Have available for HQ
review upon request or
at site visit
* Approval usually
obtained after IRB
review
Document Item
20. CVs
21. FDA related documents, if applicable
a. FDA letter for IND or IDE
b. FDA Form1571
c. FDA Form 1572
d. Investigator Brochure, Investigator
Drug Brochure (IDB)
22. Documents supporting Collaboration –
Approval document from other
collaborating institutions, when
applicable
23. Command Endorsements – Documents
recommending endorsement of the
research protocol, when applicable
24. Agreements supporting research (JRRA,
MOU, MOA, CRADA, etc.) as applicable
25. IRB minutes - Excerpt from minutes –
initial review
Continuing Reviews
1. Document approving continuing research
2. Continuing Review Report from PI
3. Original signed
consent/assent/permission documents for
all subjects
4. Document for expedited review
procedure
5. IRB minutes (excerpt) for convened
review
Amendments
1. Document approving amendment
2. Amendments to the research protocol
and/or consent documents (investigators
change, changes in procedures,
populations)
3. Document for expedited review
procedure
4. IRB minutes (excerpt) for convened
review
Investigator
File
X
IRB
File
X
Send to
DON
HRPP
N/A
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
N/A
X
X
X
X
X
X
X
N/A
X
X
N/A
N/A
X
X
N/A
X
X
X
X
X
X
X
X
N/A
X
X
N/A
X
X
DON HRPP Document List - PI-IRB-HQR FINAL (Mod) 7 Nov 2006.doc
Comments
Have available for HQ
review upon request or
at site visit
Have available for HQ
review upon request
or at site visit
Document Item
Unanticipated Problems-Adverse Events
1. Document with results of IRB review
2. Unanticipated problems or adverse event
report/form
3. Document for expedited review
procedure
4. IRB minutes(excerpt) for convened
review
Statements of Significant New Findings
Documents informing subjects (letter to
subjects, addendum to consent, revised
consent document, etc.)
FDA Annual Report
FDA report form or letter
Suspension/Reinstatement
1. Document reinstating research
2. IRB and Command review of suspension
3. Document suspending research
4. Document terminating research
5. IRB minutes(excerpt) for convened
review
Final Report / Withdrawal Notification
1. Document approving final report
2. Final Report
3. Withdrawal notification
4. Document acknowledging withdrawal
5. Document for expedited review
procedure
6. IRB minutes (excerpt) for convened
review
Publications, Presentations, or Reports
Copies of publications, presentation,
reports based on the research protocol
Investigator
File
IRB
File
Send to
DON
HRPP
X
X
X
X
X
X
N/A
X
X
N/A
X
X
X
X
X
X
X
X
X
X
X
X
N/A
X
X
X
X
X
X
X
X
X
X
X
X
X
X
N/A
X
X
X
X
X
X
X
X
X
X
N/A
X
X
X
X
N/A
DON HRPP Document List - PI-IRB-HQR FINAL (Mod) 7 Nov 2006.doc
Comments
Have available for HQ
review upon request
or at site visit
Document Item
Other Documents Not Listed Above
(Describe the document)
Investigator
File
IRB
File
Send to
DON
HRPP
X
X
N/A
DON HRPP Document List - PI-IRB-HQR FINAL (Mod) 7 Nov 2006.doc
Comments
Have available for HQ
review upon request
or at site visit